NCT00003398

Brief Summary

RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation. PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 1998

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
4 years until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

November 1, 1999

Last Update Submit

October 15, 2019

Conditions

AnemiaGraft Versus Host DiseaseLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomaBurkitt lymphomarefractory multiple myelomaWaldenstrom macroglobulinemiastage I multiple myelomastage II multiple myelomastage III multiple myelomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarefractory chronic lymphocytic leukemiachildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionadult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute promyelocytic leukemia (M3)adult acute myelomonocytic leukemia (M4)adult acute eosinophilic leukemiaadult acute basophilic leukemiaadult acute megakaryoblastic leukemia (M7)childhood acute myeloblastic leukemia with maturation (M2)childhood acute promyelocytic leukemia (M3)childhood acute myelomonocytic leukemia (M4)childhood acute eosinophilic leukemiachildhood acute basophilic leukemiachildhood acute megakaryocytic leukemia (M7)stage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesanemiagraft versus host diseaseadult acute minimally differentiated myeloid leukemia (M0)childhood acute minimally differentiated myeloid leukemia (M0)stage I childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomachildhood myelodysplastic syndromes

Interventions

anti-thymocyte globulinBIOLOGICAL
filgrastimBIOLOGICAL
cyclophosphamideDRUG
thiotepaDRUG
allogeneic bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Histologically proven malignancy or condition of the following types: Acute myelogenous leukemia (not M5 or M6) or lymphocytic leukemia in first or greater remission or early relapse OR Chronic myelogenous leukemia OR Myelodysplastic syndrome OR Aggressive or refractory non-Hodgkin's lymphoma OR Aggressive or refractory Hodgkin's disease OR Multiple myeloma at early relapse or after conventional chemotherapy to reduce tumor mass OR High risk chronic lymphocytic leukemia OR Aplastic anemia HLA-matched or 1 antigen mismatched (related or unrelated) available as donor PATIENT CHARACTERISTICS: Age: 50 and under Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL SGOT less than 4 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50% by MUGA Pulmonary: DLCO at least 50% Other: HIV negative No active extramedullary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

AnemiaGraft vs Host DiseaseLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Promyelocytic, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Basophilic, AcuteLeukemia, Megakaryoblastic, AcuteRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

Antilymphocyte SerumFilgrastimCyclophosphamideThiotepaRadiotherapy

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Barry R. Meisenberg, MD

    University of Maryland Greenebaum Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

September 1, 1998

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

US(1)